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Recruitment status
Unique ID issued by UMIN C000000391
Receipt No. R000000482
Scientific Title An open label randomized controlled trial on the preemptive risedronate intervention for renal transplant patients receiving glucocorticoid
Date of disclosure of the study information 2006/04/01
Last modified on 2006/10/18

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Basic information
Public title An open label randomized controlled trial on the preemptive risedronate intervention for renal transplant patients receiving glucocorticoid
Acronym The Preemptive Risedronate Intervention for those Undergoing Steroid therapy after Renal Transplantation (PRIUS-RTx Study)
Scientific Title An open label randomized controlled trial on the preemptive risedronate intervention for renal transplant patients receiving glucocorticoid
Scientific Title:Acronym The Preemptive Risedronate Intervention for those Undergoing Steroid therapy after Renal Transplantation (PRIUS-RTx Study)
Region
Japan

Condition
Condition Bone disease in renal transplant patients receiving glucocorticoid
Classification by specialty
Endocrinology and Metabolism Nephrology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of risedronate on bone disease in renal transplant patients receiving glucocorticoid
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in bone mineral density and bone turnover markers at two-year interval
Key secondary outcomes Ca, iP, PTH, and indices of renal function. Safety.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Active vitamin D alone (2 year)
Interventions/Control_2 Active vitamin D + risedronate (2 year)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Renal transplant patients receiving glucocorticoid treatment (2.5 mg/day of prednisolone equivalent or greater) with low bone mineral density (T-score at the lumbar spine <= -1.0) and stable renal function (serum creatinine <= 2.0 mg/dL).
Key exclusion criteria 1. Previous history of bisphosphonate treatment and/or hormone replacement therapy within one year before entry
2. Contraindication for risedronate or active vitamin D
3. Not suitable to the clinical trial as judged by a physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiro Takahara
Organization Osaka University School of Medicine
Division name Department of Advanced Technology for Transplantation
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-5111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University School of Medicine
Division name Department of Advanced Technology for Transplantation,
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-5111
Homepage URL
Email

Sponsor
Institute Department of Advanced Technology for Transplantation, Osaka University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 CRG040600075
Org. issuing International ID_1 Cochrane Renal Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2003 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2003 Year 11 Month 01 Day
Last follow-up date
2006 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 04 Month 01 Day
Last modified on
2006 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000482

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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